BEUDAMED
    FDA Adverse Event Other Summary report: N

    ICY HOT HEAT THERAPY PATCH

    MDR report key: 1002918 · Received February 8, 2008

    Report

    Report Number
    1022556-2008-00028
    Event Type
    Other
    Date Received
    February 8, 2008
    Report Date
    January 14, 2008
    Manufacturer
    CHATTEM, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER USED THE PRODUCT OFF LABEL BY WEARING THE PATCH FOR LONGER THAN EIGHT HOURS. SINCE THIS IS A DISPOSABLE SINGLE-USE DEVICE, THE PATCH IS UNAVAILABLE FOR EVAL AND ANALYSIS. THE LOT NUMBER WAS ALSO NOT PROVIDED FROM THE REPORTER AND, THEREFORE, WE ARE UNABLE TO CONDUCT ANY SORT OF TREND ANALYSIS. THIS REPORT IS BELOW THE THRESHOLD OF THE FDA'S REQUIREMENTS FOR MANDATORY REPORTING OF ADVERSE EVENTS INVOLVING MEDICAL DEVICES AS THERE IS NO EVIDENCE THAT USE OF THE PRODUCT RESULTED IN SERIOUS ADVERSE HEALTH CONSEQUENCES. INSTEAD, OUR INVESTIGATION HAS DETERMINED THAT THE PT EXPERIENCED TEMPORARY OR MEDICALLY REVERSIBLE ADVERSE HEALTH CONSEQUENCES. ACCORDINGLY, THIS MDR IS BEING SUBMITTED AS A VOLUNTARY AND PROACTIVE MEASURE BY THE MFR TO ENHANCE PRODUCT SAFETY AND PHARMACOVIGILANCE.

    Description of Event or Problem · 1

    THE CONSUMER USED THE PRODUCT ON HER LOWER BACK FOR NINE HOURS. WHEN SHE REMOVED THE PRODUCT, SOME SKIN REMAINED ADHERED TO THE PATCH. SHE DESCRIBES THE AREA AS A SELF-DIAGNOSED SECOND DEGREE BURN EQUAL WITH BLISTERS AND RED SKIN. THE AREA IS BEGINNING TO HEAL USING AN UNK PRESCRIPTION BURN OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICY HOT HEAT THERAPY PATCH IMD CHATTEM, INC. 083

    Patients

    Seq Age Sex Outcome Treatment
    1